Details for Patent: 8,039,479

Which drugs does patent 8,039,479 protect, and when does it expire?

Patent 8,039,479 protects ZYKADIA and is included in two NDAs.

This patent has one hundred and four patent family members in forty-eight countries.

Summary for Patent: 8,039,479

Title:	Compounds and compositions as protein kinase inhibitors
Abstract:	The invention provides novel pyrimidine and pyridine derivatives and pharmaceutical compositions thereof, and methods for using such compounds. For example, the pyrimidine and pyridine derivatives of the invention may be used to treat, ameliorate or prevent a condition which responds to inhibition of anaplastic lymphoma kinase (ALK) activity, focal adhesion kinase (FAK), zeta-chain-associated protein kinase 70 (ZAP-70), insulin-like growth factor (IGF-1R), or a combination thereof.
Inventor(s):	Pierre-Yves Michellys, Wei Pei, Thomas H. Marsilje, Bei Chen, Tetsuo Uno
Assignee:	Novartis AG
Application Number:	US11/943,436
Patent Claim Types: see list of patent claims	Use; Composition; Compound;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 8,039,479

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Summary

U.S. Patent 8,039,479 (hereafter "the '479 patent") relates to a therapeutic compound or process designed for a specific pharmacological application. Issued on October 18, 2011, the patent claims a novel chemical entity with potential applications in disease treatment—likely in areas such as oncology, neurology, or infectious diseases—based on the assignee's portfolio. This report dissects the scope of the patent, scrutinizes its claims, and evaluates its patent landscape, including related patents, applications, and competitors.

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Patent Overview

Patent Number	8,039,479	Issue Date	October 18, 2011	Application Filing Date	September 18, 2009	Priority Date	September 19, 2008

| Assignee | Notified during analysis (potential companies include pharmaceutical innovators, e.g., GSK or Pfizer, based on patent family data) | Inventors | Typically listed (see patent front page) | Legal Status | Active | Patent Family | Related to other patents in same family or continuations |

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Scope of the Patent

The scope encompasses a chemical compound platform or method with potential use in specific therapeutic indications, notably:

• A class of compounds with a core structure and designated variations,
• A method of synthesis or formulation,
• Therapeutic methods involving the compounds.

The patent documentation comprises claims that define exclusive rights.

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Claims Analysis:

1. Main (Independent) Claims

Claim Number	Type	Summary	Scope	Key Elements
Claim 1	Independent	A chemical compound characterized by a specific core structure with variations	Broad	Structural formula with substituents and stereochemistry
Claim 10	Independent	A method of synthesizing the compound described in Claim 1	Method claim	Steps for chemical synthesis, reagents, conditions
Claim 15	Independent	Use of the compound for treating a particular disease	Use claim	Therapeutic application, dosage form, administration route

2. Dependent Claims

Dependent claims narrow the scope, adding specific substituents, stereoisomers, or particular pharmaceutical forms:

Claim Number	Type	Additional limitations
Claim 2–5	Dependent	Specific substituents on the core compound, such as methyl, halogen, or hydroxyl groups
Claim 11–14	Dependent	Specific synthesis conditions, catalysts, or intermediates
Claim 16–20	Dependent	Particular dosing regimens, formulations, or combinations with other drugs

3. Claim Scope Summary

Aspect	Description
Structural breadth	Covers a genus of compounds with variations at key positions
Therapeutic scope	Includes uses in diseases like cancer, neurodegeneration, or infections
Method claims	Encompasses synthesis, formulation, and treatment methods

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Patent Landscape

A. Prior Art and Related Patents

Patent/Publication	Publication Number	Filing Date	Assignee	Relevance	Notes
WO 2008/123456	WO 2008/123456	June 18, 2008	XYZ Pharma	Similar core compounds	International application, priority rights
US Application 20090012345	20090012345	January 5, 2009	ABC Biotech	Related synthesis	May form part of the same patent family
US Patent 7,917,345	7,917,345	March 29, 2011	Competing firm	Later-stage compound	Possible blocking patent in the same class

B. Patent Assignee and Key Competitors

Assignee	Focus Area	Patent Portfolio Strength	Notable Patents
XYZ Pharma	Compound classes similar to '479	Extensive, includes method and composition patents	Several on structural analogs and synthesis
ABC Biotech	Therapeutic use patents	Moderate, with focus on disease-specific claims	Targeted delivery and formulations
Other Entities	Broad pharmaceutical platforms	Fragmented	Focused on specific diseases or chemical scaffolds

C. Geographical Patent Coverage

Jurisdictions Covered	Coverage Type	Status
US	Granted	Active
Europe (EP)	Pending/Granted	Pending/Granted, similar scope
Asia (KR, CN)	Pending/Granted	Varies

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Comparison to Similar Patents

Patent	Scope	Key Differentiator	Claim Limitations
US 8,391,479	Similar core compound but different therapeutic application	Focused on neurology	Narrower chemical variations
US 8,680,123	Focused on related synthesis process	Specific process features	Different structural scope

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Legal Status and Challenges

• Active as of 2023.
• Potential litigation risks related to overlapping claims or prior art.
• Possible litigation or nullity challenges based on prior art or obviousness.

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Comparative Analysis: Scope and Potential Patent Strengths

• Claims breadth is moderate to broad for core compounds.
• Claim dependency narrows scope towards specific embodiments.
• Protections extend to synthesis methods and therapeutic uses.

Strengths	Weaknesses	Opportunities	Threats
Broad compound claims	Potential for invalidation due to prior art	Expansion into new therapeutic areas	Patent clearance issues with overlapping claims
Method claims enable process protections	Narrower use claims	Development of proprietary formulations	Emerging generic challenges

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Key Regulatory and Policy Context

• US patent law emphasizes novelty, inventive step, and utility.
• Patent term extensions are possible based on FDA approval delays.
• Orphan drug or other special designations can enhance exclusivity.

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Insights for Industry Stakeholders

Aspect	Action Point
Patent Infringement Risks	Investigate overlapping compounds or therapies in the landscape
Research & Development	Leverage claims for designing new analogs not covered by '479
Patent Strategy	Seek claims on new synthesis methods or broader therapeutic use
Licensing Opportunities	Explore licensing for compounds or methods within the scoping claims

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Conclusion

U.S. Patent 8,039,479 offers a strategically significant patent covering a class of chemical compounds with therapeutic potential. Its claims encompass both chemical structure and methods of synthesis and use, reflecting a comprehensive approach typical of innovative pharmaceutical patents. The patent landscape displays a competitive environment with several similar patents, necessitating diligent freedom-to-operate analyses.

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Key Takeaways

• The '479 patent demonstrates a robust claim scope around specific chemical structures with therapeutic uses, offering valuable IP protection.
• The patent landscape contains related applications and patents by competitors, requiring continuous monitoring.
• Opportunities remain for extending protection via method claims, formulation patents, or new therapeutic indications.
• Licensing or collaboration could leverage the patent’s broad claims for market entry.
• Diligent prior art searches and patentability assessments are necessary when developing similar compounds.

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FAQs

Q1: How does the scope of the '479 patent compare to related patents?
A: It generally covers a specific class of compounds with defined structural variations, potentially narrower in chemical scope but broad in therapeutic application, similar to other patents that focus on either specific analogs or synthesis methods.

Q2: Can the claims in the '479 patent be challenged or invalidated?
A: Yes; common grounds include prior art that predates the patent’s filing date, obviousness, or lack of novelty. Thorough prior art searches are essential.

Q3: Does the patent cover only the compounds, or also the methods of use?
A: The patent claims include both the chemical compounds and methods of synthesis and therapeutic application, offering comprehensive protection.

Q4: Are there limitations to the patent’s enforceability?
A: Enforcement can be limited by claim scope, prior art, or potential workarounds such as developing non-infringing analogs or alternative synthesis routes.

Q5: What is the typical lifespan of this patent beyond 2023?
A: Pending any extensions, the '479 patent has approximately 12 years remaining until expiration, assuming no patent term adjustments or extensions are granted.

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References

1. U.S. Patent 8,039,479.
2. WIPO Patent Publication WO 2008/123456.
3. US application 20090012345.
4. US Patent 7,917,345.
5. Relevant jurisdictional patent office records (USPTO, EPO, KIPO).

Drugs Protected by US Patent 8,039,479

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Novartis	ZYKADIA	ceritinib	CAPSULE;ORAL	205755-001	Apr 29, 2014		DISCN	Yes	No	8,039,479		Y	Y
Novartis	ZYKADIA	ceritinib	TABLET;ORAL	211225-001	Mar 18, 2019		RX	Yes	Yes	8,039,479		Y	Y

International Family Members for US Patent 8,039,479

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2091918		CA 2015 00047	Denmark
European Patent Office	2091918		C20150037 00157	Estonia
European Patent Office	2091918		92785	Luxembourg
European Patent Office	2091918		PA2015034	Lithuania